(244 days)
The QuantRx Female Fertility Test is intended to measure follicle-stimulating hormone (FSH) in urine as an ancillary screen of fertility for home use by women who are attempting to conceive.
The QuantRx Female Fertility Test is a rapid, immunochromatographic assay for the measurement of follicle-stimulating hormone (FSH) in human urine. The test is performed on day 3 of the menstrual cycle by urinating directly on the absorbent tip or by dipping it in a cup of urine, and observing for the formation of colored lines after 10 minutes. A test line of color intensity greater than or equal to the reference line indicates an FSH level of at least 10 mIU/mL is indicative of diminished ovarian reserve, which corresponds to reduced fertility. A test line intensity of less than the reference line is indicative of normal ovarian reserve.
Here's a breakdown of the acceptance criteria and study details for the QuantRx Female Fertility Test, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Study: |
- Concordance (trained user) between proposed device vs. laboratory method | 89% |
| - Concordance (layperson) between proposed device vs. laboratory method | 88% |
| - Concordance trained user vs. layperson for primary study | 98% |
| Supplemental Study: - Concordance (trained user) between proposed device vs. predicate | 94% |
| - Concordance (layperson) between proposed device vs. predicate | 92% |
| - Concordance trained user vs. layperson for supplemental study | 98% |
| The device is intended to measure FSH in urine, with a test line intensity equal to or darker than the reference line (calibrated at 10 mIU/mL) indicating FSH ≥ 10 mIU/mL, and a lighter intensity indicating FSH
§ 862.1300 Follicle-stimulating hormone test system.
(a)
Identification. A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.